Senior Director, Clinical Science

About IDEAYA Biosciences

IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small‑molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first‑in‑class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody‑drug conjugates (ADCs) for molecularly defined solid tumor indications.

Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer.

South San Francisco, CA.

IDEAYA Biosciences is seeking an experienced, motivated, outgoing Senior Director of Clinical Science to work closely with the clinical leader, providing medical‑scientific expertise to one or more clinical projects. The successful candidate will be a confident person keen to take responsibility for assigned activities. Although working under the guidance of a manager and the clinical leader of the program, the Senior Director will be expected to function largely independently and will thrive in a mentored rather than a directed environment.

Reporting to:
Senior Vice President, Early Phase Clinical Development.

This position is based in our South San Francisco offices and requires onsite presence four days per week per company policy.

• With the clinical leader, writing clinical development concepts and plans for molecules at all stages of development, but more focused on early oncology development.
• Writing initial and or later drafts of protocol synopses, protocols and protocol amendments.
• Writing/reviewing informed consent forms and reviewing/adjudicating site‑specific ICF requests.
• Partnering with Clinical Operations on site selection, start‑up and communication.
• Writing or updating clinical sections of investigator brochures and leading the team that writes the initial brochure and subsequent annual updates.
• Writing/reviewing clinical/safety sections of NDAs/MAAs.
• Representing the medical (clinical) function on one or more clinical study teams, with functional support from the clinical leader.
• Serving as a member of the clinical sub team.
• Reviewing and interpreting data listings including safety data and serious adverse events.
• Assisting with or serving as primary author of clinical study reports and associated publications.
• Creating clinical study‑or‑program‑related slide decks for internal and external use.
• Training of colleagues, CRO and study site staff on the therapeutic area, molecule and protocols as appropriate.
• Organizing and participating in opinion leader advisory boards.
• Contributing to or performing therapeutic area/indication research and competitor analysis.
• Building and maintaining opinion leader/investigator networks.
• Support Health Authority (HA) interaction, accountable for providing responses to HA inspection observations and internal audits.
• Support HA updates and submissions.
• Assist Medical Monitor for Phase 1 clinical trials, accountable to the clinical lead for patient safety and providing guidance during the design, execution, and reporting for clinical studies.

• Bachelor’s degree and strong knowledge of clinical oncology gained through previous clinical development experience are required.
• Postgraduate qualification in clinical oncology (e.g., Masters degree) would be welcomed as would MD, Nurse Practitioner’s License, PharmD or PhD.
• At least 4 years of industry experience in oncology.
• Previous participation in a clinical development program is essential, preferably involvement in all stages of clinical trials (i.e., from start up to study report).
• Experience in clinical trials with small molecules preferred.
• Skilled in protocol design, interpretation, and medical monitoring.
• Experience in assessment of adverse events and safety of…